Lina Medical Aps

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)August 22, 2024
K223932SafeAir combi (SFR-combi-US)April 26, 2023
K221085LiNA OperaScope NeedleSeptember 2, 2022
K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording ModuleJanuary 17, 2020
K182224SafeAir Smoke Evacuator compactFebruary 7, 2019
K182354SafeAir Telescopic Smoke PencilDecember 14, 2018
K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and onJanuary 4, 2018
K143145SafeAir Smoke PencilDecember 4, 2014
K142757LiNA PowerBlade Plus HCOctober 23, 2014
K142538LiNA SafeAir Smoke PencilOctober 6, 2014
K132135LINA GOLD LOOP HCJanuary 31, 2014
K132837LINA POWERBLADE PLUSDecember 19, 2013
K130305LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZEJuly 24, 2013
K101458LINA XCISE MODEL MOR-1515March 11, 2011
K070315LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8October 30, 2007
K063025LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-December 1, 2006